KGXFDA Class 1 · 21 CFR 880.5240
Tape And Bandage, Adhesive
Device family · General Hospital
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
187
Manufacturers
25
Flagged signals
13
Adverse-event reports
4,490
Code matrix
| FDA product code | KGX |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5240 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2012 | 3 | 285.0 | 590 |
| Other | 2013 | 34 | 40.6 | 1,276 |
| Other | 2013 | 10 | 33.3 | 282 |
| Other | 2014 | 17 | 20.3 | 293 |
| Other | 2012 | 8 | 9.6 | 53 |
| Other | 2012 | 7 | 8.4 | 38 |
| Injury | 2017 | 9 | 2.6 | 12 |
| Injury | 2023 | 7 | 2.6 | 9 |
| Injury | 2012 | 4 | 2.6 | 4 |
| Injury | 2022 | 4 | 2.6 | 4 |
| Injury | 2025 | 4 | 2.6 | 4 |
| Injury | 2025 | 11 | 2.4 | 12 |
| Injury | 2022 | 7 | 2.0 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 1 family · 4,490 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Beiersdorf, Inc. | 15 | 1994 | — |
| 3M COMPANY | 6 | 1990 | — |
| Convatec, A Division of E.R. Squibb & Sons | 6 | 1994 | — |
| Johnson & Johnson Professionals, Inc. | 6 | 1984 | — |
| Abco Dealers, Inc. | 4 | 1985 | — |
| Smith & Nephew, Inc. | 4 | 1994 | — |
| DEROYAL INDUSTRIES, INC. | 3 | 1994 | — |
| Johnson & Johnson Medical, Inc. | 2 | 1995 | — |
| The Kendal Co. | 2 | 1982 | — |
| 3M Health Care, Ltd. | 2 | 1993 | — |
| ACME UNITED CORP. | 1 | 1983 | — |
| Conmedcorp | 1 | 1991 | — |
| Ethicon, Inc. | 1 | 1981 | — |
| Iberhospitex, S.A. | 1 | 1988 | — |
| Coloplast A/S | 1 | 1989 | — |
| Visitec Co. | 1 | 1990 | — |
| Warner-Lambert Co. | 1 | 1981 | — |
| Empi | 1 | 1994 | — |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1989 | — |
| Medtronic Vascular | 1 | 1992 | — |
| Quinton, Inc. | 1 | 1989 | — |
| Marine Polymer Technologies, Inc. | 1 | 1997 | — |
| Johnson & Johnson International | 1 | 1994 | — |
| Pharmacia Deltec, Inc. | 1 | 1987 | — |
| Dale Medical Products, Inc. | 1 | 1991 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
SERAGARD INJECTION PATCH · Platinum Services, Inc.510(k) · 2000-06-21
CARE BAND ANTIBACTERIAL BANDAGES · Aso Corp.510(k) · 1999-02-17
SYVEK PATCH · Marine Polymer Technologies, Inc.510(k) · 1997-12-22
ADHESIVE BANDAGES WITH OTC DRUG · Johnson & Johnson Consumer Products, Inc.510(k) · 1996-01-17
TARGETT PATCH · Cutting Edge Technologies, Inc.510(k) · 1995-12-21
PARALLEL · Johnson & Johnson Consumer Products, Inc.510(k) · 1995-11-22
DERMIVIEW HYPOALLERGENIC CLEAR TAPE · Johnson & Johnson Medical, Inc.510(k) · 1995-10-30
STERILE PLASTIC DRESSING · Smith & Nephew, Inc.510(k) · 1994-11-07
BAND-AID(TM) BRAND ADHESIVE BANDAGE · Johnson & Johnson Consumer Products, Inc.510(k) · 1994-10-03
BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP · Johnson & Johnson Consumer Products, Inc.510(k) · 1994-10-03
SHIPPERT PRESSURE BANDAGE · Denver Splint Co.510(k) · 1994-09-28
EMPI TAPE PATCHES · Empi510(k) · 1994-08-23
DERMIVIEW CLEAR TAPE · Johnson & Johnson International510(k) · 1994-08-22
COVERLET ADHESIVE DRESSING · Beiersdorf, Inc.510(k) · 1994-07-29
KIT PAK DRESSING CHANGE TRAY · Kit Pak, Inc.510(k) · 1994-07-20
SURGICAL ADHESIVE TAPE · Raleigh Lions Clinic For the Blind, Inc.510(k) · 1994-06-30
ACE SPORTS TAPE · Becton Dickinson Consumer Products510(k) · 1994-06-13
CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM · Convatec, A Division of E.R. Squibb & Sons510(k) · 1994-03-01
SPYROGEL WOUND DRESSING · Polymint Industrial Co. , Ltd.510(k) · 1994-02-09
EPISEAL ADHESIVE WOUND CLOSURE STRIPS · Deroyal Industries, Inc.510(k) · 1994-02-04
MEDIMAC BANDAGE · Enquay Pharmaceutical510(k) · 1994-01-25
3M TEGADERM HP TRANSPARENT DRESSING · 3M Health Care, Ltd.510(k) · 1993-12-27
MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION · Scott Health Care510(k) · 1993-09-10
TISSUE ISOLATION AND RETRIEVAL BAG · Advanced Surgical, Inc.510(k) · 1993-09-07
I.V. START KIT (AHC-50-54954 · American Healthcare Corp.510(k) · 1993-08-27
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.